Clinical Prediction Rule for Clinical Lumbar Instability

Identifying the Subgroup of Patient With Mechanical Low Back Pain Who Have Clinical Lumbar Instability

The aim of this study is to determine if assessment of additional measures of trunk neuromuscular control will improve the ability to identify patients with low back pain who successfully respond to trunk stabilization exercises.

Question: What clinical characteristics are associated with patients that respond positively to a program of core stabilization exercises?

Hypothesis: Clinical characteristics that show a decrease in trunk motor control will be associated with a positive response to stabilization exercises.

Study Overview

• Status: Terminated
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Core Stabilization

Detailed Description

Clinical identification of individuals with mechanical low back pain who would benefit from a program of stabilization exercises has been a struggle for the physical therapy profession. While changes in trunk muscle recruitment and motor control have been linked to patients with chronic low back pain and hypothesized to be adaptations for spinal instability, this has not been systematically established. However, a connection between spinal instability, poor trunk motor control, and low back pain is plausible. The real problem lies with the clinical identification of the subgroup of patients in either the acute or chronic phases of low back dysfunction who would most benefit from this approach to intervention.

In creating their preliminary clinical prediction rule, Hicks et al (2005), looked at many variables including patient demographics and characteristics, hip and trunk motion, special tests for instability, and functional measures of muscle performance. However, measures of the performance of core stabilizing muscles and assessment of trunk dynamic control/ coordination were not included as potential variables. The aim of this study is to determine if assessment of additional measures of trunk neuromuscular control will improve the ability to identify patients with low back pain who successfully respond to trunk stabilization exercises.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University
    • West Chester, Pennsylvania, United States, 19380
      • Optimum Physical Therapy Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. duration of the current episode of low back pain less than 3 months,
2. average pain intensity over past 3 days at least 4 on an 11 point (0 = no pain, 10 = worst pain ever) numeric pain rating scale,
3. no medical intervention for low back pain in last 6 months,
4. Oswestry score greater than 25%

Exclusion Criteria:

1. permanent structural spinal deformity (e.g., scoliosis)
2. history of spinal fracture or diagnosis of osteoporosis
3. diagnosis of inflammatory joint disease
4. signs of systemic illness or suspected non-mechanical LBP (i.e. spinal tumor or infection)
5. previous spinal surgery
6. frank neurological loss, i.e., weakness and sensory loss
7. history of neurologic disease that required hospitalization,
8. active treatment of another medical illness that would preclude participation in any aspect of the study or any lower extremity injury that would potentially alter trunk movement in standing
9. leg length discrepancy of greater than 2.5 cm.
10. pregnancy
11. vestibular dysfunction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Low back pain; Individuals with current low back pain.

Other: Core Stabilization; The 8-week program emphasizes use of specific local stabilizing muscles (transverse abdominis[TrA], lumbar multifidus[LM]) to restore active control to the trunk. Emphasis is on training isometric co-contractions and a progression (3 stages) based upon a motor learning paradigm. Stage 1: neutral position of the spine and activation of the TrA and LM. Performance feedback is emphasized and monitored through observation and palpation. Stage 2: maintenance the co-contraction while performing movements of the trunk and the upper and lower extremities. Trunk conditioning is also emphasized. Feedback is gradually reduced. Stage 3: maintenance of the co-contraction while performing exercises on an unstable surface or during perturbation of the activity. Random practice patterns are used to enhance motor learning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index	measure of functional limitation	Baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Scale	measure of preceived pain	Baseline, 8 weeks

Collaborators and Investigators

• Sponsor: Drexel University
• Investigators: Principal Investigator: Sheri P. Silfies, PT, PhD, Drexel University

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: March 10, 2010
• First Submitted That Met QC Criteria: March 10, 2010
• First Posted (Estimate): March 11, 2010

Study Record Updates

• Last Update Posted (Estimate): November 5, 2013
• Last Update Submitted That Met QC Criteria: November 4, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: low back pain; physical therapy; core stabilization
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: DRX18590